Status:
COMPLETED
Incretin Effect and Use After Clinical Islet Transplantation
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansio...
Detailed Description
This is a single centre non-randomized pilot study. Subjects will be recruited from the current cohort of islet transplant recipients at the University of Alberta. The primary objective of the study ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects must meet the following criteria to be enrolled in this study:
- Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta.
- Insulin independent for 3 months or longer after islet transplant.
- Early graft dysfunction as defined by:
- HbA1c \>6% (but less than 7.5%); or
- fasting glucose \> 7 mmol/L (126 mg/dl); or
- random glucose \> 10 mmol/L (180 mg/dl), and
- Total insulin use of \< 10 units/day.
- C-peptide positive.
- Able to provide informed consent.
- Exclusion Criteria:
- Subjects who meet any of the following criteria will be excluded from the study:
- Unable to provide informed consent.
- Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months.
- Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators).
- Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs:
- Hypersensitivity to sitagliptin or pantoprazole for any component of the formulation.
- Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/L (males), ≥ 124 µmol/L (females) or abnormal creatinine clearance; or estimated by Glomerular Filtration Rate (GFR) \<50 ml/min/1.73m2).
- Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
- Uncontrolled hyperglycemia
- Any subject that in the opinion of the investigator would not be a good candidate for study participation.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00768651
Start Date
October 1 2008
End Date
December 1 2011
Last Update
June 18 2015
Active Locations (1)
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1
University of Alberta - Clinical Islet Transplant Program
Edmonton, Alberta, Canada, T6G2C8